FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Aid, Surgical, Viscoelastic
PMA: P840064
·
Supplement: S006
·
Decision Dec 1, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Basic Information
- Device Name
- Aid, Surgical, Viscoelastic
- Trade Name
- VISCOAT(TM)
- PMA Number
- P840064
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- LZP
- Generic Name
- AID, SURGICAL, VISCOELASTIC
- Regulation Number
- 886.4275
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 1, 1987
- Date Received
- October 21, 1987
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZP | Aid, Surgical, Viscoelastic | FDA class 3 | Ophthalmic |